Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
NCT ID: NCT01850368
Last Updated: 2019-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2012-10-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotactic ablative radiotherapy
Stereotactic ablative radiotherapy for HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
Stereotactic ablative radiotherapy
The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by \>48 hours.
At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy.
Interventions
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Stereotactic ablative radiotherapy
The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by \>48 hours.
At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of \> 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of \> 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
* Eastern Cooperative Oncology Group performance status 0 or 1
* HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
* Cirrhotic status of Child Pugh class A or B7
* Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
* Patient or guardian must be able to provide verbal and written informed consent
Exclusion Criteria
* Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
* Uncontrolled inter-current illness except liver cirrhosis
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Dongnam Institute of Radiological & Medical Sciences
OTHER
Soon Chun Hyang University
OTHER
Inha University Hospital
OTHER
Incheon St.Mary's Hospital
OTHER
Gyeongsang National University Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Korea Cancer Center Hospital
OTHER
Responsible Party
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Mi-Sook Kim
Doctor
Principal Investigators
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Mi-Sook Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Locations
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Gyeongsang National University Hospital
Jinju, Gyeongsang-nam-do, South Korea
Dongnam Institute of Radiological & Medical Sciences
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Catholic University Incheon St. Mary's Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Countries
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References
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Yoon SM, Lim YS, Won HJ, Kim JH, Kim KM, Lee HC, Chung YH, Lee YS, Lee SG, Park JH, Suh DJ. Radiotherapy plus transarterial chemoembolization for hepatocellular carcinoma invading the portal vein: long-term patient outcomes. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):2004-11. doi: 10.1016/j.ijrobp.2011.03.019. Epub 2011 May 27.
Kim JY, Chung SM, Choi BO, Kay CS. Hepatocellular carcinoma with portal vein tumor thrombosis: Improved treatment outcomes with external beam radiation therapy. Hepatol Res. 2011 Sep;41(9):813-24. doi: 10.1111/j.1872-034X.2011.00826.x. Epub 2011 Jun 22.
Tanaka A, Morimoto T, Yamaoka Y. Implications of surgical treatment for advanced hepatocellular carcinoma with tumor thrombi in the portal vein. Hepatogastroenterology. 1996 May-Jun;43(9):637-43.
Kang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8.
Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.
Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
Other Identifiers
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KCT0000542
Identifier Type: REGISTRY
Identifier Source: secondary_id
KROG 13-02
Identifier Type: REGISTRY
Identifier Source: secondary_id
K-1209-001-007
Identifier Type: OTHER
Identifier Source: secondary_id
K-1209-001-007
Identifier Type: -
Identifier Source: org_study_id
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